Catalog Number 04837975001 |
Device Problem
Circuit Failure (1089)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/21/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The customer replaced the batteries, but the problem was not solved.No moisture, debris or corrosion was observed by the customer in the battery compartment.The meter reportedly did not appear physically damaged and the strip guide was clean.The meter was requested for investigation.
|
|
Event Description
|
We received an allegation of a display issue with a coaguchek xs meter.The reporter stated the meter would continually reset or give an error.When the meter did display a result, the result could not be read because the screen only partially lights up.Upon completion of a display check, the reporter saw 666 instead of 888.The meter memory was reviewed and the reporter saw what looked to be 45.5 sec but was unable to see the date.No results were misinterpreted due to the display issue.
|
|
Manufacturer Narrative
|
The customer's meter was received for investigation.The meter¿s circuit board was tested for damage or contamination and it was found the circuit board was contaminated.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.This can cause both the power and display issue.Medwatch fields d9 and h3 were updated.
|
|
Search Alerts/Recalls
|